RecallReported September 30, 2026
Class I recall by Boston Scientific Corporation
Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER II/5/ST/65/0…
FDA's enforcement report of September 30, 2026 lists a Class I recall by Boston Scientific Corporation of Maple Grove, MN. Product: Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER II/5/ST/65/0…. Status: Ongoing.
On the record
- Recalling firm
- Boston Scientific Corporation
- Location
- Maple Grove, MN
- Classification
- Class I
- Status
- Ongoing
- Recall number
- Z-3214-2026
- Product type
- Devices
- Recall initiated
- 2026-08-24
- Reported by FDA
- 2026-09-30
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
More
Watch Boston Scientific Corporation
A free account shows the last 7 days of every record. Pro adds a watchlist: one email when FDA acts on a company you name.
From FDA enforcement reports. The record may have changed since it was read.
Approve Suite is not affiliated with FDA, or with Boston Scientific Corporation.
See something wrong on this page? Write to info@approvesuite.com and we will check it against the source. How corrections work.